FDA Adverse Event
Death
Summary report: N
X SERIES
MDR report key: 3892104
·
Received June 19, 2014
Report
- Report Number
- 1220908-2014-01539
- Event Type
- Death
- Date Received
- June 19, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 4, 2014
- Manufacturer
- ZOLL MED CORP
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PT, THE DEVICE REBOOT/RESET ITSELF. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361788 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MED CORP | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |